The White House and federal agencies on Tuesday released their fall regulatory agendas, setting the stage for several new health care rules, Axios' "Vitals" reports.
The agendas are released by the White House Office of Information and Regulatory Affairs and serve as a roadmap for the types of regulatory changes federal agencies plan to take over the next few months, The Hill reports. The Trump administration previously has focused on eliminating rules, as opposed to issuing new ones.
A senior administration official in a call with reporters on Tuesday said the administration's deregulation efforts have reduced regulatory costs by $33 billion since President Trump took office. The official said last year federal agencies eliminated a total of 176 regulations the administration said were ineffective. However, regulatory advocates have criticized the administration for eliminating rules that have broadened societal benefits, such as those to combat climate change and improve air and water quality.
Health care items on the administration's regulatory agenda
HHS' regulatory agenda for fall 2018 lists 188 rules that agencies, including CMS and FDA, would like to prioritize in coming months, CQ News reports.
According to the list, HHS and its agencies in coming months plan to propose rules to:
- Update the Medicare Part D bidding process;
- Revise federal anti-kickback protections;
- Increase oversight of state-run health insurance exchanges;
- Strengthen eligibility verification for exchange enrollees who receive federal subsidies;
- Give grandfathered health plans more flexibility on the exchanges;
- Allow state Medicaid programs to charge low-income beneficiaries premiums and co-payments; and
- Require prior authorization for chiropractors with unusual billing practices or a high number of rejected claims.
The list also suggests HHS is planning to re-examine patient privacy rules that protect patients who have received mental health care or substance use disorder treatment, as well as an overhaul of rules related to Medicaid managed care. HHS also could revisit a rule issued under former President Barack Obama targeting dialysis chains and charities that prioritize patients with private coverage over those with Medicaid or Medicaid. The rule ultimately was struck down in court.
FDA continues focus on youth tobacco use
FDA's agenda for the first time mentions a rule related to flavored cigars. The agency wrote, "Evidence shows that flavored tobacco products, especially those that are sweet or are described with terms attractive to kids, appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Characterizing flavors in cigars, such as strawberry, grape, orange, and cocoa, enhance taste and make them easier to use."
The proposal does not mention flavors for electronic cigarettes or other electronic nicotine delivery systems (ENDS), which also are popular among youth. However, FDA Commissioner Scott Gottlieb in a release said, "We're also continuing to press forward with aggressive steps to address the epidemic of e-cigarette use among youth, through our Youth Tobacco Prevention Plan. This comprehensive plan aims to stop youth use of, and access to, tobacco products--especially e-cigarettes."
The agency also listed previously posted rules that would create:
- Manufacturing requirements for tobacco products;
- Battery testing standards for ENDS products;
- Safety standards for ENDS products; and
- Recordkeeping requirements for tobacco product manufacturers (Baker, "Vitals," Axios, 10/18; Wheeler, The Hill, 10/16; Wang, Inside Health Policy, 10/17 [subscription required]; Wilkerson, Inside Health Policy, 10/17 [subscription required]; Siddons et al., CQ News, 10/17 [subscription required]).
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